(MCRI) Animal Ethics Committee PREAMBLE

Transcription

Murdoch Childrens Research Institute (MCRI) Animal Ethics
Committee
PREAMBLE
The provision of a high standard of animal welfare is necessary to sustain excellence
in research.
The use of animals for scientific purposes and teaching is governed by Victorian
Legislation, the Prevention of Cruelty to Animals Act 1986 and Regulations (“the Act
and Regulations”) and the National Health and Medical Research Council (NHMRC)
Australian Code of Practice for the Care and Use of Animals for Scientific Purposes
7th edition (“the Code”).
For the purposes of the Code and the Act, the Animal Ethics Committee (AEC) at
Murdoch Childrens Research Institute (MCRI) is the legally constituted animal ethics
committee. The AEC’s membership, responsibilities, terms of reference and
procedures must comply with the requirements of the 7th edition of the Code, the Act
and Regulations.
The primary responsibility of the AEC is to ensure, on behalf of MCRI, that all care
and use of animals is conducted in compliance with the Code, the Act and
Regulations, and MCRI policies, procedures and guidelines. The role of the AEC is
to ensure that the use of animals is justified, provides for the welfare of those
animals and incorporates the principles of Replacement, Reduction and Refinement.
The primary role of the MCRI Animal Ethics Committee is to ensure a uniform and
high standard of animal welfare and ethics in animal experimentation throughout The
Campus, which incorporates MCRI, The Royal Children’s Hospital & The University
of Melbourne Department of Paediatrics.
To this end, the following terms of reference have been prepared to ensure
uniformity and a clear understanding of the method of operation of the MCRI AEC.
MCRI Executive recommends that these Guidelines be followed by the AEC.
MCRI AEC Terms of Reference
Version Approved: November 2012
Approved By: MCRI Executive Board
Review Date: November 2015
1.
TERMS OF REFERENCE
The Terms of Reference of the Animal Ethics Committee includes the following
provisions:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
xii.
xiii.
xiv.
xv.
xvi.
xvii.
To approve guidelines for the care of animals that are bred, held and used for
scientific purposes at The Campus Animal Facilities on behalf of MCRI
To monitor the acquisition, transport, production, housing, care, use and fate
of animals
To recommend to MCRI Executive any measures needed to ensure that the
standards of the Code are maintained
To observe the procedures authorised by MCRI Executive for appointment,
reappointment and retirement of members of Animal Ethics Committee
To require all members to declare any conflict of interest
To observe the procedures authorised by MCRI Executive to deal with
situations in which a conflict of interest arises
To examine and approve, approve subject to modification, or reject written
proposals relevant to the use of animals for scientific purposes
To approve only those studies for which animals are essential and justified
and which conform to the requirements of the Code. This should take into
consideration factors including ethics, the impact on the animal or animals
and the anticipated scientific, environmental or educational value
To withdraw approval for any project that is conducted in a manner not
compliant with the Code, Act and Regulations
To authorise the emergency treatment of any animal, with reference to
Section 2.2.36 of the Code
To examine and comment on all MCRI Executive plans and policies that may
affect the welfare of animals used for scientific purposes
To maintain a record of proposals and projects, including the outcomes of the
AEC deliberations
To comply with the reporting requirements of MCRI Executive, the Act and
Regulations, and the Code
To perform all other duties required by the Code, Act and Regulations
In association with The Campus Partners, ensure that staff and students
(particularly post-graduate students) are adequately educated and trained in
the care and use of animals for scientific purposes
To perform all other duties required by MCRI Executive, including compliance
with policies, regulations and guidelines, annual audit and inspection of
animal facilities and laboratories, and submission of annual and other reports
To have these terms of reference publicly available
2.
AEC MEMBERSHIP
The membership of the AEC must enable it to fulfil its terms of reference and be
compliant with Sections 2.2.2 – 2.2.8 of the Code. It must comprise at least five
persons, including a separate person appointed to each of the following categories.
Chairperson: a person who either holds a senior position in the institution, or if an
external appointee, be given a commitment by the institution to provide the
necessary support and authority to carry out the role. It is recommended that the
Chairperson is an additional appointment to Categories A to D members except in
the exceptional circumstance that a category member is a late apology.
Category A member(s): a person with qualifications in veterinary science and with
experience relevant to the activities of the institution. Veterinarians who lack this
experience must familiarise themselves with the biology and clinical characteristics
of the species of animals used.
Category B member(s): a suitably qualified person with substantial recent
experience in the use of animals in scientific or teaching activities. This will usually
entail possession of a higher degree in research.
Category C member(s): a person with demonstrable commitment to, and
established experience in, furthering the welfare of animals, who is not employed by
or otherwise associated with the institution, and who is not involved with the care and
use of animals for scientific purposes. Veterinarians with specific animal welfare
interest and experience may meet the requirements of this category. While not
representing an animal welfare organisation, the person should, where possible, be
selected on the basis of active membership of, and nomination by, such an
organisation.
Category D member(s): a person who is both independent of the institution and
who has never been involved in the use of animals in scientific or teaching activities,
either in their employment or beyond their under-graduate education. Category D
members should be viewed by the wider community as bringing a completely
independent view to the AEC, and must not fit the requirements of any other
Category.
Animal Facility Manager/representative (ex officio): a person responsible for the
routine care of animals from within the institution.
Other members appointed / co-opted by the Committee
AEC Secretary
The role of the Chairperson is to represent the AEC in negotiations with the MCRI
Executive and to ensure that the AEC operates in accord with the Code, the Act and
Regulations, and MCRI policies, procedures and guidelines. The responsibilities of
the Chairperson are detailed in Section 2.2.9 of the Code.
A Deputy or Acting Chairperson may be appointed from the AEC membership, to act
for the Chairperson in their absence. The MCRI Corporate Operations Manager and
the Animal Facility Manager/representative shall be ex officio members of the AEC
and attend meetings. If in attendance, the MCRI Corporate Operations Manager and
the Animal Facility Manager/representative are to give a report at each meeting.
3.
APPOINTMENT AND RETIREMENT OF MEMBERS
i.
ii.
iii.
iv.
4.
The MCRI Executive is responsible for appointing the Chairperson and
Membership of the AEC. The MCRI Executive recommends that the
Chairperson interview proposed new AEC members to ensure their suitability
to serve on AEC, and that the person fills the criteria for their Category and to
reveal any biases which could be detrimental to the workings of the committee
The new member is to be sent a letter of appointment from the MCRI
Executive. The AEC Secretary will organise all external AEC members to be
given a volunteer appointment at MCRI.
External persons are covered by MCRI Professional Indemnity policy for the
Committee work they perform for MCRI
Appointment of a Member may be terminated by the MCRI Executive by
sending a letter of termination
MEETINGS
i.
ii.
iii.
iv.
Meetings should be held every two months (February, April, June, August,
October and December), to allow interaction of AEC members and to enable
the AEC to fulfil its terms of reference (Code Section 2.2.13)
The operating procedures of the AEC must comply with Sections 2.2.10 –
2.2.48 of the Code
AEC members should inspect all animal facilities and laboratories on the
campus at least annually. Inspections should be conducted in accordance
with the Act and Regulations, the Code (Sections 2.2.29–2.2.36 and Section
4). Authority for inspection of facilities and projects at remote sites may be
delegated to an agent or another AEC; the inspection report is considered at a
meeting of the AEC
Minutes must be maintained that record decisions, inspections and other
aspects of the AEC’s operation
5.
QUORUM
Sections 2.2.10 (ii) and (iii) of the Code define a quorate meeting to be:
i.
The presence at meetings of at least one member from each of Categories A,
B, C and D. A meeting that is conducted face-to-face.
ii.
If more than four AEC members are present, Category C and D members
should represent not less than one third of the members present.
iii.
If there is a last minute cancellation by a category and an alternate cannot be
arranged then the AEC must decide if it is appropriate for the chair to act in
another category capacity.
6.
EXECUTIVE
i.
ii.
iii.
iv.
7.
The AEC Chairperson may establish an Executive, which must include the
Chairperson and at least one member from Category A, Category C or
Category D. Other members of the AEC may also be appointed to the
Executive
The Executive may not have a permanent membership but may consist of a
different representative group of the AEC depending on the item being
reviewed
The Executive may review reply to queries raised by the AEC, approve minor
amendments to projects and deal with emergencies. Any decisions by the
Executive must be reviewed and ratified by the AEC at its next meeting (Code
Section 2.2.11)
Executive members are required to declare if they have a conflict of interest
with an item and another member must be appointed for consideration of the
item
CONSENSUS DECISION-MAKING AND VOTING RIGHTS OF
MEMBERS
i.
ii.
iii.
iv.
Decisions by the AEC with regard to approval, modification or rejection of a
project proposal, or withdrawal of approval for a project must comply with
Sections 2.2.20 – 2.2.23 of the Code, and should be made on the basis of
consensus.
When consensus is achieved, then this decision is recorded. If the project is
rejected, this should be recorded in the Minutes with the reasons for the
rejection.
Where consensus cannot be reached after reasonable effort to resolve
differences, the AEC should explore with the applicant(s) ways of modifying
the project that may lead to consensus.
The Secretary of the AEC, the MCRI Corporate Operations Manager and the
Animal Facility Manager/s have no voting rights.
8.
CONFIDENTIALITY & SECURITY
i.
ii.
9.
Members and attendees of the AEC must comply with any confidentiality
policies of MCRI
In the interests of confidentiality and security it is recommended that all
approved applications and confidential documents be collected by the AEC
Secretary and shredded and/or deleted from computers at the end of each
AEC meeting. In special circumstances and with agreement of the AEC
secretary and/or chairperson, committee members may be allowed to keep
copies of applications
CONFLICT OF INTEREST
When a research proposal of which the chairperson or a member is an investigator is
considered by the AEC, the minutes of meeting should clearly record and reflect that:
Where Chairperson is an Investigator
i.
ii.
iii.
iv.
The Chairperson vacates the Chair,
The meeting is then chaired by the Deputy/Acting Chairperson at that point
The Chairperson is required to absent himself/herself from the meeting during
discussion of his/her proposal and only respond to questions directed to
him/her upon returning to the room. The Chairperson will not participate in
voting on the proposal
The Chairperson assumes the Chair at the conclusion of consideration of that
proposal.
Where a member is an Investigator
i.
ii.
iii.
10.
The member concerned is required to absent himself/herself from the meeting
during discussion of his/her proposal and only respond to questions directed
to him/her upon returning to the room. This member will not participate in
voting on the proposal.
An Investigator is a researcher who is involved in the conduct of the
experiments. The "Person to act in Principal/Chief Investigator's absence", as
named in the research proposal application form, is generally considered not
a researcher unless he /she is actively involved in the research project
If an AEC member is not an investigator on a project being conducted by their
department they should declare that they do not have a conflict of interest.
This declaration will be recorded in the minutes.
PROCEDURES FOR APPROVING ANIMAL USE PROPOSALS
The procedures followed by the AEC when considering proposals for breeding,
holding and use of animals for scientific purposes must comply with Sections 2.2.15
– 2.2.25 and Section 4 of the Code. Only those scientific, teaching and husbandry
activities that conform to the requirements of all relevant Sections of the Code and
legislation may be approved.
i.
New proposals and renewal of existing projects must be considered and
approved only at quorate meetings of the AEC.
ii.
iii.
iv.
v.
vi.
vii.
11.
i.
ii.
iii.
12.
The AEC must be satisfied that the proposed use of animals is justified by
weighing the predicted scientific or educational value of the proposal against
the potential impact on the welfare of the animals. An essential component of
this assessment by the AEC involves consideration of the steps taken by the
applicant to comply with the principles of Replacement, Reduction and
Refinement specified in the Code
Decisions should be made in a manner that is fair to applicants, acceptable to
all members and in accordance with the procedure detailed above at point 7.
Investigators must be informed of decisions in writing
A register of all proposals to the AEC, including the outcomes of the
Committee’s deliberations, must be maintained
Decisions must be made as promptly as possible
Scientific or teaching activities involving the use of animals must not start
before written approval is given
SUSPENSIONS AND WTIHDRAWAL OF APPROVAL
If an inspection detects activities that are non-compliant with the code, the
AEC will ensure that such activities are ceased immediately and remedial
action is initiated (section 2.2.33 of the code)
The AEC may suspend approval of a project at their discretion. Investigators
will be advised of this suspension in writing within 7 days of such a decision.
The principal investigator will be advised of reasons why suspension has
occurred and will be provided with steps to reinstate ethical approval for their
project
The AEC may withdraw approval of a project at their discretion. Investigators
will be advised of this suspension in writing within 7 days of such a decision.
The investigator will be advised of reasons why withdrawal of ethical approval
has occurred. Further remedial action may be initiated. The institution, the
animal facility manager and the license nominee will also be advised of the
withdrawal of ethical approval
EMERGENCY TREATMENT OR EUTHANASIA OF AN ANIMAL
In compliance with 2.2.35 of “the code” the AEC authorise The Campus Animal
Facility staff to respond to emergencies including unexpected adverse outcomes. In
case of emergencies, before the animal is treated or euthanased, all steps should be
taken to contact the principal investigator or their representative (2.2.36 of the code).
If emergency treatment or euthanasia is instigated, the principal investigator and
AEC should be notified promptly. An adverse event report written by the principal
investigator and is required to be submitted to the AEC within 48 hours of the event.
The AEC secretary will report all adverse events to the AEC members and the MCRI
executive board.
13.
REPORTING
The AEC will submit a written report to the MCRI Executive on its activities at least
annually.
14.
i.
ii.
iii.
iv.
v.
vi.
vii.
OPERATING PROCEDURES
A cut-off date is advertised on the MCRI AEC intranet for all AEC meeting
dates
All studies submitted by the advertised cut-off date will be placed on the
agenda for the advertised meeting
After each AEC meeting the minutes will be completed and sent to the
chairman for final review. Upon final review, letters will be drafted, and signed
by the AEC chairman or authorised delegate. The principal investigator will be
sent a signed hard copy of the letter via email.
Investigators have a 3-month period to reply to queries.
The AEC will determine at their meeting the course of action to take for each
item including approving the item with no changes, approving the item with
changes or requesting a resubmission of the project with the option of inviting
the investigator to attend the meeting.
If an item is approved out of session the investigator will be provided with
signed original copy of the approval certificate via email.
The animal facility manager will be advised of all approved projects within one
week of approval.
15. PROCEDURES FOR HANDLING ANIMAL ETHICS CONCERNS AND
GRIEVANCES
Grievances concerning AEC Operation
If a member of the AEC or a researcher has any grievance about the operation of
that committee, they should discuss this, in confidence, with the Chairperson of the
AEC. If the grievance cannot be resolved they should then take their concerns to the
MCRI Executive.
Animal Welfare Concerns Reported to the AEC
i.
ii.
iii.
If the animal facility, academic or other staff or students have any enquiries or
concerns about the well being of animals held at MCRI for use in breeding,
research or teaching, these concerns should be reported to the Chairperson
of the AEC, or to the MCRI Corporate Operations Manager.
All complaints, concerns or enquiries will be treated confidentially and
sympathetically. All personnel and students may voice concerns without
jeopardising their employment, careers or coursework.
If the complaint is of a serious nature, or if the matter cannot be resolved, then
the MCRI Executive should be notified in a timely manner.
16.
i.
INSPECTION OF ANIMAL FACILITIES AND LABORATORIES
MCRI recommends that The Campus Animal Facilities and laboratories be
monitored by the AEC at least annually.
Inspection parties should consist of at least one AEC member who is external
to the institution
A report of the inspection should be written and include the names of those
who attended, observations, any identified problems, follow-up and outcomes.
The inspection report should be an agenda item for consideration by the
Committee
ii.
iii.
iv.
17.
MODIFICATIONS
Examples of Modifications Include:
Addition of new staff
A small change in procedure
A change in animal numbers
An extension of duration of the project
Although there is no limitation as to how many modifications are allowed within
the approved duration of the research project, minor amendments are only
allowed, generally speaking, when there is no substantial change in the overall
nature or direction of the project.
NOTE :
Change in animal numbers: change of 10% or less for proposals with more than
250+ animals is generally acceptable. Exceptions to this guideline are left to the
discretion of the AEC and the request needs to be fully justified.
Extension of duration of the project: generally no longer than one year, except that a
request for a longer extension may be granted upon request and justification.
19.
BUREAU OF ANIMAL WELFARE
Refer to for Bureau of Animal Welfare (BAW) website for an explanation of Licenses
(http://www.dpi.vic.gov.au/agriculture/innovation-and-research/animals-used-research-andteaching/licensing-of-scientific-procedures/scientific-procedures-premise-licence).
Annual Returns
All holders of Scientific Procedures Premises Licences (SPPL) and Specified
Animals Breeding Licences (SABL) are required by the legislation to complete an
Annual Return of Animal Usage each calendar year and submit it to the Bureau of
Animal Welfare by the specified deadline. The Bureau supplies a form designed for
the purpose.
Alterations to the SPPL or SABL
The Bureau needs to be notified promptly of:
Alterations to AEC membership
Additions / deletions of animal facilities or laboratories to Licenses
Change to the nominated person or their contact details
A form designed for the purpose is supplied by the BAW. Changes should be notified
within 2 weeks of the alteration.
Fieldwork notification
The Bureau needs to be notified (prior to commencement) of projects approved by
the MCRI AEC conducted at sites other than those listed on the Scientific
Procedures Premises Licence. These sites are termed “Field Work”. The use of any
animal at MCRI Small Animal Facility or RCH Large Animal Facility for research
purposes must be reviewed and approved by the MCRI AEC.
Death as an endpoint
'Death as an end-point' refers to those rare procedures where death is the deliberate
measure for evaluating biological or chemical processes, responses or effects (see
the Australian Code of Practice page 3). These procedures may only be carried out
for the achievement of prescribed outcomes, and only where the objective cannot be
achieved by any other scientific means (Prevention of Cruelty to Animals
Regulations 1997). 'Death as an end point' procedures must be approved by the
Minister for Agriculture. An application for ministerial approval to conduct these
procedures must be sent to the BAW.
Auditing of SPPL, SABL and AEC’s
The Department BAW conducts triennial audits of licenses and AECs to assess
compliance with the relevant legislation and Codes of Practice. Audit panel members
are suitably qualified veterinarians and/or animal welfare officers. The audit protocol
is found on the BAW webpage.
Training for AEC members
The BAW provides complimentary half-day training for new and pre-existing AEC
members. The BAW and the Animal Welfare Advisory Committee hold an annual
Scientific Procedures Seminar at the end of the year for AECs, Animal Facility Staff
and Researchers. The MCRI Executive recommends introductory training from the
BAW for all new AEC members with no prior experience or training.

(MCRI) Animal Ethics Committee PREAMBLE

Transcription

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